Regulatory Specialist
Regulatory Affairs Specialist - Medical Devices
Location: Belgium (Hybrid)
Industry: Medical Devices / Medical Equipment Manufacturing
About the Role
An established international medical device organisation is seeking a Regulatory Affairs Specialist to support regulatory market access, product lifecycle management, and compliance activities across multiple EMEA markets.
Working within a collaborative Regulatory Affairs, Quality Assurance and Compliance team, you will partner with manufacturers, distributors, commercial teams and regulatory authorities to ensure products remain compliant and available across assigned territories.
Key Responsibilities
Regulatory Submissions & Market Access
- Coordinate and manage regulatory registrations across multiple international markets.
- Prepare and maintain registration dossiers, ensuring submissions meet local regulatory requirements and timelines.
- Liaise with manufacturers, distributors, commercial teams and regulatory authorities to support registration activities.
- Maintain regulatory documentation and ensure records remain current and audit ready.
- Support ongoing compliance obligations related to medical device and IVD products.
Product Lifecycle Management
- Assess and coordinate regulatory activities associated with product changes.
- Review change notifications and ensure appropriate internal stakeholder approval.
- Maintain oversight of product change documentation and implementation activities.
- Support regulatory review of product claims, labelling and marketing materials.
Regulatory Intelligence
- Monitor evolving medical device and IVD regulations.
- Interpret new regulatory requirements and communicate impacts to key stakeholders.
- Provide practical regulatory guidance to support business decision-making.
- Build relationships with relevant industry and regulatory stakeholders.
Continuous Improvement
- Participate in process improvement initiatives across Regulatory Affairs and Quality functions.
- Identify regulatory risks and opportunities to strengthen compliance processes.
- Share regulatory knowledge and support internal training activities.
- Contribute to broader team objectives and cross-functional projects.
Requirements
- Bachelor's degree in Life Sciences, Biomedical Sciences, Pharmacy, Regulatory Affairs or a related discipline.
- Previous Regulatory Affairs experience within the medical device industry.
- Understanding of medical device regulations and international registration processes.
- Experience supporting product registrations, regulatory submissions and lifecycle management activities.
- Strong project coordination and organisational skills.
- Ability to manage multiple priorities in a fast-paced international environment.
- Excellent stakeholder management and communication skills.
- Fluent English required; additional European languages are beneficial.
- Analytical, detail-oriented and proactive approach to problem solving.
- Strong interest in regulatory compliance and continuous professional development.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.Â
That's why we recommend registering your resume so you can be considered for roles that have yet to be created.Â
Yes, we help with CV and interview preparation. From customized support on how to optimize your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.